Mannitol for bowel preparation: Efficacy and safety results from the SATISFACTION randomised clinical trial.

Abstract

Background: Bowel preparation represents a significant issue to high-quality colonoscopy. Oral mannitol requires a single dose, is of low volume, and has a pleasant taste and rapid action.

Aims: This SATISFACTION study compared single-dose (same day) oral mannitol 100 g/750 mL with standard split-dose PEG-ASC2 L (MoviPrep®).

Methods: The primary endpoint was the proportion of patients with adequate bowel cleansing. Secondary endpoints included efficacy (adenoma detection rate, caecal intubation rate, time of evacuation), safety (intestinal gases concentration, haemato-chemical parameters, adverse events), and patient satisfaction.

Results: The study included 703 patients (352 treated with mannitol and 351 with PEG-ASC). Mannitol was not inferior to PEG-ASC for the primary endpoint (91.1 % and 95.5 %, respectively; p-value for the non-inferiority =0.0131). There was no significant difference for secondary efficacy endpoints. The acceptability profile was significantly better in the mannitol group for ease of use, taste, and willingness to reuse (p < 0.0001 for all). The concentration of intestinal gases (H₂, CH₄) was similar between groups and well below those potentially critical.

Conclusions: The SATISFACTION study indicated that low-volume, single-dose mannitol may satisfy an unmet clinical need since it was more acceptable to the patient and not inferior to the split-dose PEG-ASC for bowel cleansing efficacy.